This completed clinical investigation evaluated the safety, resorption profile, and clinical performance of a resorbable medical barrier intended to support natural tissue regeneration. The study was conducted in alignment with the requirements of the EU Medical Device Regulation (MDR) and ISO 14155:2020, with Pure Clinical serving as the CRO responsible for full project oversight.
“This study showcased our ability to manage technically demanding clinical investigations under the MDR framework — combining scientific rigor, operational excellence, and transparent collaboration with clinical sites to deliver credible post- market and
Designing a protocol that effectively balanced scientific depth with regulatory compliance for a bioresorbable material.
Coordinating multidisciplinary teams across several clinical sites to ensure consistency in patient selection, procedure execution, and follow-up.
Implementing robust monitoring and data management procedures to ensure data integrity and adherence to Good Clinical Practice (GCP).
This prospective, single-arm interventional investigation involved adult participants undergoing a standard tissue repair procedure. Pure Clinical managed all stages of the study — from protocol development and ethics submissions to site training,
monitoring, and data analysis. Comprehensive oversight ensured high-quality data collection, effective communication between stakeholders, and timely completion of the clinical report.
Comprehensive CRO oversight ensured MDR compliance and robust clinical evidence.
This project involved a comprehensive update and adaptation of the technical documentation for two Class III substance-based medical devices — an ear spray and ear drops — originally certified under the MDD. The main objective was to align all documentation with the requirements of Regulation (EU) 2017/745 (MDR) and to address all Notified Body observations raised during the review process.
This study assessed the diagnostic specificity and sensitivity of a new in vitro diagnostic device, the HIV-1 RNA Quantitative Diagnostic Kit, by comparing it with a commercially available CE-marked RT-qPCR test. The evaluation used leftover human EDTA plasma specimens to ensure the accurate detection of HIV-1 RNA.
This study evaluated the clinical performance of the HIV Ag/Ab diagnostic test, designed for the qualitative detection of HIV p24 antigen and antibodies to HIV-1 and HIV-2 in human serum or plasma.
